Ibuprofen

Description

The product, identified by SPL Code 34089-3, is an ibuprofen formulation available in multiple dosage forms, including caplets and capsules. It is offered in various strengths, specifically 500 mg, 300 mg, and 50 mg, with packaging sizes that include 24 count options. The labeling for these different dosages and packaging configurations is referenced in accompanying images.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, toothache, backache, menstrual cramps, the common cold, muscular aches, and minor pain of arthritis. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and over are advised to take 1 caplet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. It is imperative that the total daily dosage does not exceed 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may elicit severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

The use of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is notably elevated in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using anticoagulants or steroid medications, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The likelihood of these serious cardiovascular events is heightened with the use of higher than recommended doses or prolonged use.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Patients should be instructed to discontinue use and consult a healthcare provider if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. Patients should also seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

The use of ibuprofen carries a warning for potential severe stomach bleeding, particularly in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or use other NSAIDs concurrently. Patients should be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, there is an increased risk of heart attack, heart failure, and stroke associated with NSAID use, including ibuprofen. This risk is heightened when the medication is used in higher doses or for extended periods. Patients should be aware of symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Common adverse reactions may include gastrointestinal discomfort, which can lead to the need for medical consultation if pain persists beyond 10 days or if fever worsens or lasts more than three days. Patients should also seek medical advice if they notice any new symptoms or if redness or swelling occurs in the area of pain.

Before initiating treatment with ibuprofen, patients are encouraged to consult a healthcare provider if they have a history of serious side effects from pain relievers or fever reducers, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also advisable to discuss the use of ibuprofen with a doctor or pharmacist if the patient is under care for any serious condition, is taking aspirin for cardiovascular protection, or is using any other medications.

Drug Interactions

The concomitant use of ibuprofen with aspirin may diminish the cardioprotective effects of aspirin when utilized for the prevention of heart attack or stroke. It is advisable to monitor patients closely for any signs of reduced efficacy of aspirin in such scenarios.

Pharmacodynamic interactions are also noted with the use of ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and nonprescription medications such as aspirin and naproxen. The combined use of these agents significantly elevates the risk of gastrointestinal bleeding. Therefore, caution is warranted, and healthcare providers should consider alternative pain management strategies or closely monitor patients for gastrointestinal complications.

Additionally, the co-administration of ibuprofen with anticoagulants or corticosteroids may further increase the risk of gastrointestinal bleeding. It is recommended that healthcare professionals assess the necessity of ibuprofen in patients receiving these medications and implement appropriate monitoring protocols to mitigate potential adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Ibuprofen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 caplet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets within a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. Therefore, it is crucial for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

In this population, it is recommended to administer the smallest effective dose and to ensure that the directed dosage is not exceeded. Close monitoring for any signs of gastrointestinal bleeding is advised, given the heightened risk associated with advancing age.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully consider the potential benefits and risks when prescribing this medication to pregnant patients, especially in the later stages of pregnancy.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. It is particularly important to avoid the use of ibuprofen at 20 weeks of gestation or later unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, healthcare providers should weigh the potential benefits against the risks when considering this medication for lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for these patients to discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function may be warranted in this population to ensure appropriate management and to mitigate potential risks associated with the use of the medication.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals are advised to call 1-800-222-1222 for expert guidance.

Prompt intervention is crucial in managing overdose situations to mitigate potential adverse effects and ensure patient safety.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports of allergic reactions have been documented, including hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, stomach bleeding has been noted, particularly in patients with certain risk factors.

There is an increased risk of cardiovascular events, including heart attack, heart failure, and stroke, associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs). Surveillance data has also revealed instances of gastrointestinal bleeding, renal impairment, and elevations in liver enzymes.

Severe skin reactions have been reported, including cases of Stevens-Johnson syndrome and toxic epidermal necrolysis. Other adverse reactions include dizziness, headache, and gastrointestinal discomfort.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be cautioned against using this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it should not be used immediately before or after heart surgery.

Healthcare providers should inform patients to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Patients should also be advised to stop use and seek medical attention if they exhibit symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

Patients should be instructed to stop using the medication if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When using this product, patients should be advised to take it with food or milk if they experience stomach upset. Healthcare providers should encourage patients to consult a doctor before use if they have experienced problems or serious side effects from pain relievers or fever reducers in the past.

Patients should also be advised to seek medical advice if the warning regarding stomach bleeding applies to them, or if they have a history of stomach issues such as heartburn. It is important to discuss any existing conditions, including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke, as well as the use of diuretics, before starting this medication.

Furthermore, patients should be encouraged to consult a doctor or pharmacist if they are under care for any serious condition or if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the effectiveness of aspirin. Lastly, patients should be reminded to inform their healthcare provider or pharmacist about any other medications they are currently taking.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a controlled room temperature of 20-25ºC (68-77ºF) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container to prevent exposure to extreme temperatures or environmental conditions. Special handling requirements should be followed to ensure the integrity of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

This file contains official product information for Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)